Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]

Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.

Secondary Outcome Measures:

Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'

Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]

The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]

Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]

The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 [ Time Frame: Study Baseline, Week 12 ] [ Designated as safety issue: No ]

The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.

Biological: BOTOX®

BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.

Other Names:

onabotulinumtoxinA

botulinum toxin Type A

Drug: solifenacin placebo

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Active Comparator: solifenacin

Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

Biological: BOTOX®

BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.

Other Names:

onabotulinumtoxinA

botulinum toxin Type A

Drug: solifenacin

Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks.

Other Name: Vesicare

Drug: Botox placebo (normal saline)

Botox placebo (normal saline) intradetrusor injection at Day 1.

Placebo Comparator: placebo

Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

Biological: BOTOX®

BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.

Other Names:

onabotulinumtoxinA

botulinum toxin Type A

Drug: Botox placebo (normal saline)

Botox placebo (normal saline) intradetrusor injection at Day 1.

Drug: solifenacin placebo

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01767519